FDA Approves Pill with Sensor that Digitally Tracks if Patients have Ingested their Medication

The U.S. Food and Drug Administration today approved the first drug in the U.S. with a digital ingestion tracking system. Abilify MyCite (aripiprazole tablets with sensor) has an ingestible sensor embedded in the pill that records that the medication was taken. The product is approved for the treatment of schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I disorder and for use as an add-on treatment for depression in adults.

The system works by sending a message from the pill’s sensor to a wearable patch. The patch transmits the information to a mobile application so that patients can track the ingestion of the medication on their smart phone. Patients can also permit their caregivers and physician to access the information through a web-based portal.

“Being able to track ingestion of medications prescribed for mental illness may be useful for some patients,” said Mitchell Mathis, M.D., director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research. “The FDA supports the development and use of new technology in prescription drugs and is committed to working with companies to understand how technology might benefit patients and prescribers.”

It is important to note that Abilify MyCite’s prescribing information (labeling) notes that the ability of the product to improve patient compliance with their treatment regimen has not been shown. Abilify MyCite should not be used to track drug ingestion in “real-time” or during an emergency because detection may be delayed or may not occur.

Schizophrenia is a chronic, severe and disabling brain disorder. About 1 percent of Americans have this illness. Typically, symptoms are first seen in adults younger than 30 years of age. Symptoms of those with schizophrenia include hearing voices, believing other people are reading their minds or controlling their thoughts, and being suspicious or withdrawn. Bipolar disorder, also known as manic-depressive illness, is another brain disorder that causes unusual shifts in mood, energy, activity levels and the ability to carry out day-to-day tasks. The symptoms of bipolar disorder include alternating periods of depression and high or irritable mood, increased activity and restlessness, racing thoughts, talking fast, impulsive behavior and a decreased need for sleep.

Abilify MyCite contains a Boxed Warning alerting health care professionals that elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Abilify MyCite is not approved to treat patients with dementia-related psychosis. The Boxed Warning also warns about an increased risk of suicidal thinking and behavior in children, adolescents and young adults taking antidepressants. The safety and effectiveness of Abilify MyCite have not been established in pediatric patients. Patients should be monitored for worsening and emergence of suicidal thoughts and behaviors. Abilify MyCite must be dispensed with a patient Medication Guide that describes important information about the drug’s uses and risks.

In the clinical trials for Abilify, the most common side effects reported by adults taking Abilify were nausea, vomiting, constipation, headache, dizziness, uncontrollable limb and body movements (akathisia), anxiety, insomnia, and restlessness. Skin irritation at the site of the MyCite patch placement may occur in some patients.

Prior to initial patient use of the product, the patient’s health care professional should facilitate use of the drug, patch and app to ensure the patient is capable and willing to use the system.

Abilify was first approved by the FDA in 2002 to treat schizophrenia. The ingestible sensor used in Abilify MyCite was first permitted for marketing by the FDA in 2012.

The FDA granted the approval of Abilify MyCite to Otsuka Pharmaceutical Co., Ltd. The sensor technology and patch are made by Proteus Digital Health.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Source: U.S. Food and Drug Administration

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Common Heartburn Medicines May Link to Kidney Trouble

If you’re one of the millions of Americans who takes one of a class of anti-reflux meds such as Nexium, Prilosec and Prevacid, take heed: These drugs have been linked to higher odds of kidney trouble.

The study couldn’t prove cause-and-effect — it’s possible that folks who need these heartburn medicines are simply more prone to kidney disease for other reasons. But the review of data did show a link.

The medicines in question are called proton pump inhibitors (PPIs). They reduce stomach acid production and are among the most widely prescribed medications in the world.

According to a team led by Dr. Charat Thongprayoon, of Bassett Medical Center in Cooperstown, N.Y., recent research has suggested an increased risk of kidney problems for people who take the drugs, but those findings were inconsistent.

Probing deeper, the researchers reviewed data from five studies that included a total of nearly 537,000 people.

They found that people who took a PPI were a third more likely to develop chronic kidney disease or kidney failure than those who didn’t take the drugs.

The findings were to be presented Saturday at the annual meeting of the American Society of Nephrology (ASN), in New Orleans.

“This study demonstrates a significant association between the use of PPIs and increased risks of chronic kidney disease and kidney failure,” Thongprayoon said in an ASN news release.

He stressed that cause-and-effect wasn’t confirmed. However, Thongprayoon believes that doctors “should consider whether PPI therapy is indicated for patients. Chronic use of PPIs should be avoided if not really indicated.”

Two kidney specialists said the new research does have value.

“It is important to always evaluate potential side effects — not only of medications but of treatments and procedures in general,” said Dr. Ernesto Molmenti. He directs adult and pediatric kidney transplantation at Northwell Health in Manhasset, N.Y.

Dr. Maria DeVita helps direct kidney care at Lenox Hill Hospital in New York City. She noted that PPIs — some of which have gained over-the-counter status in recent years — “are one of the most commonly ingested medications worldwide.”

Also, DeVita said, “PPIs were originally used for a limited time, but now, people may continue to use them for years.”

While it remains to be proven that the drugs cause kidney trouble, “we should reconsider our prolonged use of PPIs from time to time to make sure that the benefits outweigh potential risks,” she said.

Experts note that findings presented at medical meetings are typically considered preliminary until published in a peer-reviewed journal.

Source: HealthDay


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New Study on Targeted Precision Medicine to Extend Lives of Men with Advanced Prostate Cancer

Researchers from the University of Southampton are set to lead a new precision medicine study for prostate cancer which has the potential to extend the lives of 9,000 men every year in the UK.

The study is part of a major new research programme launched today by men’s health charity, Prostate Cancer UK.

The research drive will tailor treatments for men based on the genetic make-up of their cancer and marks a significant shift from the traditional ‘one size fits all’ approach to treatment, towards identifying what drives an individual man’s cancer, and which drugs will work best to stop it in its tracks.

The £1.4million study involves researchers Glasgow, Belfast, Manchester and London and is led by Dr Simon Crabb, Associate Professor in Medical Oncology at the University of Southampton.

“Women diagnosed with advanced breast cancer receive treatment depending on the type of disease they have and are assigned the drugs that will work best for their individual cancer” Dr Crabb said. “This precision medicine approach currently isn’t available to men with prostate cancer which is why this research is so important.

“Investigators at over 100 hospitals across the UK have been assembled to study thousands of tumours and develop tests, which will help clinicians understand which drug or combination of drugs will work best for an individual patient. This is more than just a clinical trial and researchers from both the lab and the clinic will be working side by side in a bid to bring about change as quickly as possible. As a result, we’ll be in a position to open the first arm of the trial to patients from as early as next year, whilst we continue to develop new treatments and precision medicine approaches in the lab.”

The researchers will focus on developing targeted treatment pathways specifically for men with advanced disease not yet resistant to hormone therapy. The study, which has been co-funded by Prostate Cancer UK, the Movember Foundation and the Distinguished Gentleman’s Ride will tackle three key issues:

  • Identify changes in the DNA make up of prostate cancer cells not yet resistant to hormone therapy, that are responsible for driving the cancer cell growth.
  • Develop a test which can easily detect these genetic changes.
  • Establish which drugs best target the genetic changes and prevent the cancer from spreading further.

Dr Iain Frame, Director of Research at Prostate Cancer UK said: “Every man’s prostate cancer is unique to him and so not surprisingly the way men respond to treatments varies enormously. Clinicians are in effect left to treat patients ‘in the dark’ – with little idea as to which treatments will work best for which men.

“However, this new research programme could be game changing, providing clinicians with the much clearer picture they desperately need. It will enable them to go straight to the right treatment for each individual man, saving precious time for those men who often have little time left.”

Prostate cancer is the most common cancer in men, with over 47,000 new diagnoses every year in the UK. Around a quarter of these are diagnosed after the cancer cells have spread to other parts of the body, reducing the chances of successful treatment and survival.

Men diagnosed with advanced prostate cancer are typically treated with hormone therapy, and move on to life extending treatments such as Docetaxel, Abiraterone and Enzalutamide once hormone therapy has stopped working. The first study of Prostate Cancer UK’s precision medicine programme will specifically focus on men with advanced prostate cancer before it has become resistant to hormone therapy.

Source: University of Southampton


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Long-term Aspirin Use Reduces the Incidence of Digestive Cancers

The long-term use of aspirin has been shown to significantly reduce the incidence of digestive cancers, new research presented today at the 25th UEG Week has found.

In a study involving over 600,000 people, researchers compared patients who were prescribed aspirin over a long period (for at least six months, average duration of aspirin prescribed was 7.7 years) with non-aspirin users and assessed the incidences of a number of cancers. Those prescribed with aspirin showed a 47% reduction in liver and oesophageal cancer incidence, a 38% reduction in gastric cancer incidence, a 34% reduction in pancreatic cancer incidence and a 24% reduction in colorectal cancer incidence.

Digestive cancers account for almost a quarter of cancer cases in Europe. Colorectal, gastric and pancreatic cancer are within the top five cancer killers throughout the continent, with digestive cancers representing 30.1% of cancer deaths.

The effect of long-term use of aspirin on cancer incidence was also examined for cancers outside of the digestive system. Here, a significant reduction was shown for some (leukaemia, lung and prostate) but not all (breast, bladder, kidney and multiple myeloma) cancers.

Aspirin is used across the globe to treat a number of health conditions, ranging from short-term pain relief to long-term prescriptions. Whilst the use of aspirin is subject to debate within the medical community, a recent study found that patients who stopped taking aspirin were 37% more likely to have an adverse cardiovascular event, such as a heart attack or stroke, than those who continued with their prescription.

Lead researcher, Professor Kelvin Tsoi from the Chinese University of Hong Kong, presented the study today at the 25th UEG Week in Barcelona. “The findings demonstrate that the long-term use of aspirin can reduce the risk of developing many major cancers” commented Professor Tsoi. “What should be noted is the significance of the results for cancers within the digestive tract, where the reductions in cancer incidence were all very substantial, especially for liver and oesophageal cancer.”

Source: EurekAlert!


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Blood Thinners May Also Protect Brains of A-Fib Patients

Blood thinners may pull double duty for people with the heart rhythm disorder atrial fibrillation: New research suggests they help prevent dementia as well as stroke.

Because atrial fibrillation increases the risk for stroke, people with the condition are often prescribed blood thinners (also known as anticoagulants) to prevent blood clots that can cause a stroke.

Atrial fibrillation also increases the risk for dementia. During the study, more than 26,000 of the 440,000 participants, all with atrial fibrillation, were diagnosed with dementia.

At the time they joined the study, about half of the participants were taking oral anticoagulants, such as warfarin, Eliquis (apixaban), Pradaxa (dabigatran), Savaysa (edoxaban) or Xarelto (rivaroxaban).

The researchers found that people taking anticoagulants were 29 percent less likely to develop dementia than were those who were not taking the blood thinners.

When the researchers focused on people who continued to take the drugs, they found an even larger reduction (48 percent) in the risk for dementia. They also found that the sooner people started taking blood thinners after their diagnosis of atrial fibrillation, the lower their risk for dementia.

Along with not taking blood thinners, the strongest predictors for dementia were age, Parkinson’s disease and alcohol abuse, according to the study, published Oct. 25 in the European Heart Journal.

The findings strongly suggest that blood thinners reduce the risk for dementia in people with atrial fibrillation, but proving that would not be possible, the Swedish researchers said.

“In order to prove this assumption, randomized placebo-controlled trials would be needed, but such studies cannot be done because of ethical reasons,” researchers Leif Friberg and Marten Rosenqvist, of the Karolinska Institute in Stockholm, said in a journal news release. “It is not possible to give placebo to [atrial fibrillation] patients and then wait for dementia or stroke to occur.”

However, the findings show that people with atrial fibrillation should start taking blood thinners as soon as possible after their diagnosis and continue to take the drugs, Friberg noted.

“Patients start on oral anticoagulation for stroke prevention but they stop after a few years at an alarmingly high rate,” he said. “In the first year, approximately 15 percent stop taking the drugs, then approximately 10 percent each year.”

“If you know that [atrial fibrillation] eats away your brain at a slow but steady pace and that you can prevent it by staying on treatment, I think most patients would find this a very strong argument for continuing treatment,” he said.

Source: HealthDay


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